Roche Accu-Chek Inform II in Critical Care Areas

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Do any of you use the Roche Accu-Chek Inform II? Are the meters being used in the critical care areas? What measures did you follow to make sure that you are compliant with CAP?

4 Replies

Tianna Stein

Wed Apr 24, 2024 at 12:55PM

Hey there. So you have to do the following (and what I do). I am currently pushing my hospital system to move to the Nova meters because managing this is challenging as a team of one with half a dozen other testing platforms.

Perform a validation in critical care areas to compare accuchek results to lab instrument results. This is the tough part because you have to get as many populations as possible.
Ensure that operators of the devices in those areas are RN and above only (no patient care techs, CNAs, LPNs, etc) - this comes down to the two year degree in science and experience. Sometimes, a person without an RN degree will qualify but you have to have transcripts on file. Follow CLIA rules for moderate complexity testing personnel.
New operators have to do 6 month competency
Competency has to include the 6 elements used for non-waived testing
Perform instrument to instrument correlations and instrument to lab correlations - twice per year on each device
Perform linearity on all critical care devices twice per year
Ensure your test activity menu has POCT glucose non waived on it

RoseAnne Ippolito

Wed Apr 24, 2024 at 10:20PM

My healthcare system currently uses this glucometer. Years ago we defined our critically ill population as any patient residing in an ICU. Therefore, using the Accu-Chek in our ICU settings is off label use and makes it a high complexity test. Current CLIA regulations allow nurses to perform high complexity tests (at least in my state under CAP) because their degree is the equivalent of a biological degree. However, rules have changed. As of December 28, 2024 a degree in nursing will no longer be the equivalent of a biological degree. So if a nurse doesn’t have enough biology and chemistry credits, they will not be able to perform high complexity tests. Current users are grandfathered in as long as they don’t leave the ICU. Our Medical director will not redefine what critically Ill means. We are in the process of hopefully, moving towards replacing our Accu-Cheks with the Nova StatStrip as its FDA approved for use for critically ill patients. We will no longer have to perform correlations, monitor lab versus meter results or show 6 steps of competency assessment as the device will be waived test in all departments. Going to a new meter is the best decision for my system.

Ken C

Mon Apr 29, 2024 at 6:45PM

We define the specific critical disease states as listed by the manufacturer. Not everyone in a critical care unit has a disease state that will interfere with peripheral circulation. Patients with critical conditions that can interfere with glucose measurement must have glucoses performed by the central lab as directed by our SOP.

Amanda Burgess

Mon May 06, 2024 at 12:57PM

Hi RoseAnne,

What state are you in? This is the first time I am hearing about the RN rule changing. Do you have the website where this is stated?

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Roche Accu-Chek Inform II in Critical Care Areas